VESIERRA 25 MG/ML SOLUTION FOR INJECTION

Transcript

Package leaflet: Information for the patient
Vesierra 5 mg/ml solution for injection/infusion
Vesierra 25 mg/ml solution for injection/infusion
Esketamine
Read all of this leaflet carefully before you are given this medicine because it contains important
information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, pharmacist or nurse.
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
 If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

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What is in this leaflet
1.
What Vesierra is and what it is used for
2.
What you need to know before you are given Vesierra solution for injection/infusion
3.
How Vesierra solution for injection/infusion is given
4.
Possible side effects
5.
How to store Vesierra solution for injection/infusion
6.
Contents of the pack and other information
1.

What Vesierra is and what it is used for

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Vesierra belongs to one of a group of medicines called anaesthetic agents, which are
used to put you to sleep during an operation.
Vesierra can be given alone or in combination with other anaesthetic agents.
Vesierra can be given as a pain relief/anaesthesia in emergency situations.
Vesierra can be used for supplementing regional or local anaesthesia.

2.

What you need to know before you are given Vesierra solution for injection/infusion

You should not be given Vesierra solution for injection/infusion
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if you are allergic to esketamine or any of the other ingredients of this medicine (listed in section 6)
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if high blood pressure or increased pressure in the brain (intracranial pressure) is a serious risk for you
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if you have chest pain (angina) and/or cardiac diseases (in such case, Vesierra solution for
injection/infusion should not be given as the only anaesthetic)
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if you have a condition called eclampsia or pre-eclampsia (which is a complication of pregnancy that
causes high blood pressure).
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in combination with xanthine derivatives and ergometrine (used to induce labour).
If any of the above applies to you, you should not be given this medicine.
Warnings and precautions
Talk to your doctor or nurse before Vesierra solution for injection/infusion is given to you if any of the
following apply to you, to help them decide if Vesierra solution for injection/infusion is suitable for
you:
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if you have a weak heart (cardiac insufficiency) and untreated high blood pressure
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if you have chest pain

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if you have increased pressure in the brain and damage or disease of the central nervous system.
Raised pressure around the brain or spinal cord has been seen in people given ketamine (a similar
product) as an anaesthetic.
if you need an eye examination or eye surgery in which pressure in the eye must not be increased
if you are under the influence of alcohol
if you have or have had severe psychiatric problems
if you have an overactive thyroid (insufficiently treated hyperthyroidism)
situations during childbirth which require relaxed uterus muscle (e.g., threat of a uterus rupture,
prolapsed umbilical cord)
if you have liver disease
if you have a history of drug abuse or addiction.

Out-patient treatment
You should be accompanied home after out-patient anaesthesia and you should not drink alcohol within the
next 24 hours.

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Other medicines and Vesierra
Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
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Sympathomimetics (for example adrenaline or noradrenaline), thyroid hormones and vasopressin may
lead to an increase in blood pressure and in heart rate or heart rhythm disorders.

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Xanthine derivatives (for example aminophylline, theophylline) which may lead to fits or convulsions
and therefore these combinations should be avoided.

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Hypnotics (sleeping pills), benzodiazepines (for example diazepam) or neuroleptics used for mental
disorders, as the duration of effect of Vesierra may be prolonged.

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Barbiturates and opiates (such as morphine) given together with Vesierra may prolong the recovery
phase after the anaesthetic.

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The anaesthetic effect of some gas anaesthetics (for example halothane, isoflurane, desflurane,
sevoflurane) is increased by administration of Vesierra so lower doses may be needed.

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The effect of muscle relaxants such as pancuronium-type suxamethonium –type may be prolonged due
to the use of Vesierra.

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Vesierra should not be used in combination with ergometrine (used to induce labour).
Vesierra used with drugs that may inhibit CYP3A4 enzyme activity may require a decrease in dose of
Vesierra
Vesierra used with drugs that may induce CYP3A4 enzyme activity may require an increase in dose

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Using Vesierra with food, drink and alcohol
As with all general anaesthetics you will be asked to fast for 4 to 6 hours before you are due to receive
Vesierra solution for injection/infusion.
You should not drink alcohol within 24 hours of having this anaesthetic.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Pregnancy

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This medicine will not be used during pregnancy unless your doctor has advised you that there is no safer
alternative. It could cause problems with the baby’s breathing rate if used during delivery.
Breast-feeding
This medicine can pass into breast-milk however it is unlikely to affect the baby when it is used at the
recommended doses.
Driving and using machines
You should not drive or operate machinery for at least 24 hours after receiving this medicine. Vesierra
results in reduced response times which are important in situations requiring special alertness, e.g., when
driving a car.

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The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber or in the information
provided with the medicine and
o It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this
medicine.
Vesierra solution for injection/infusion contains sodium
This medicinal product contains 3.2 mg sodium per ml (strength 5 mg/ml)
This medicinal product contains 1.2 mg sodium per ml (strength 25 mg/ml). Patients on a low-salt diet
should take this in consideration.
3.

How Vesierra solution for injection/infusion is given

Vesierra will only be given to you by or under the supervision of an anaesthetist (a specialist in
anaesthetics).
It is given as a slow injection into your vein (intravenous) or muscle (intramuscular). If necessary, the
injection can be repeated or the preparation can be given as an infusion.
If you have any further questions on the use of this product, ask your doctor, nurse or anaesthetist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects usually depend on the dose and speed of injection and usually get better without treatment.
Common (may affect up to 1 in 10 people)
 Recovery reactions after anaesthesia. These include vivid dreams, nightmares, dizziness and restlessness.
 Blurred vision
 Temporary increase in heart beat, increase in blood pressure
 Effects on breathing during anaesthesia
 Nausea and vomiting, increased salivation
Uncommon (may affect up to 1 in 100 people)
 Increased body movements (for example muscle twitching), which can resemble seizures, and increased
eye movements

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Double vision, increased pressure in the eye
Rash
Pain and/or redness at the injection site

Rare (may affect up to 1 in 1,000 people)
 Severe allergic reactions
 Irregular heart beat or slower heart beat
 Low blood pressure
Unknown (frequency cannot be estimated from the available data)
 Hallucinations, dysphoria, anxiety and disorientation
 Abnormal liver function test results
 Liver injury
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.
5.
How to store Vesierra solution for injection/infusion
Keep this medicine out of the sight and reach of children.

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Do not freeze.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What Vesierra contains
 The active substance is esketamine
Vesierra 5 mg/ml solution for injection/infusion
1 ml solution for injection/infusion contains 5 mg esketamine as 5.77 mg of esketamine hydrochloride
1 ampoule of 5 ml solution for injection/infusion contains 25 mg of esketamine as 28.85 mg of esketamine
hydrochloride.
Vesierra 25 mg/ml solution for injection/infusion
1 ml solution for injection/infusion contains 25 mg esketamine as 28.85 mg of esketamine hydrochloride
1 ampoule of 2 ml solution for injection/infusion contains 50 mg of esketamine as 57.7 mg of esketamine
hydrochloride.
The other ingredients are sodium chloride, hydrochloric acid (for pH-adjustment), water for injections.
See section 2.
What Vesierra looks like and contents of the pack
The solution for injection/infusion is a clear solution for injection contained in a clear glass ampoule for
single use only.

-----------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
For full prescribing information please refer to the SmPC. The following is an abbreviated version:
Posology and method of administration
Posology
Esketamine can only be administered by or under the supervision of a specialist of anaesthesiology. The
equipment for maintenance of vital functions should be available.

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Where possible, the use of esketamine should follow the ordinary guidelines regarding fasting, 4 to 6 hours
before anaesthesia.
Although esketamine has only a minor effect on the protective reflexes of the pharynx and the airways, the
possibility of aspiration of fluid or solid materials cannot be completely excluded. High doses or too rapid
intravenous administration can cause respiratory depression.
Increased salivation may be associated with the use of esketamine and can be prevented by giving the patient
atropine or another anticholinergic.
Esketamine is given as a slow intravenous or intramuscular injection. If needed, injection can be repeated or
the preparation can be administered as an infusion.
For induction of general anaesthesia 0.5 to 1 mg/kg of esketamine is given intravenously or 2 to 4 mg/kg
intramuscularly.
For maintenance of general anaesthesia, half the initial dose is injected as needed, generally every 10 to
15 minutes.
Esketamine can also be administered as a continuous infusion at a dose of 0.5 to 3 mg/kg/h.

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Dose reduction is required in patients with multiple injuries and in patients with a poor general condition.
For example the dose in patients in shock should be reduced; as a guideline about half the normal dose
should be administered.
For analgesic supplementation of regional and local anaesthesia 0.125 to 0.25 mg esketamine/kg/h is
administered as intravenous infusion.
For analgesia in emergency medicine 0.25 to 0.5 mg esketamine/kg is administered intramuscularly or
0.125 to 0.25 mg/kg as a slow intravenous injection.
As with other general anaesthetic agents, the individual response to esketamine is somewhat varied
depending on the dose, route of administration, age of patient, and concomitant use of other agents, so that
dosage recommendation cannot be absolutely fixed. The dose should be titrated against the patient’s
requirements.
Paediatric population
Dosage of esketamine across subgroups of paediatric patients of different ages has not been adequately
studied. Based on the limited information available, dosage in paediatric patients is not expected to differ
substantially from that in adults.
Note:
In paediatric surgery, as well as in emergency medicine, esketamine hydrochloride is mostly used on its own;
in case of other indications a combination with hypnotics is recommended.
Method of administration
For instructions on reconstitution of the medicinal product before administration, see ”Special precautions
for handling.”
Special warnings and precautions for use
Esketamine is metabolized in the liver and hepatic clearance is required for termination of clinical effects.
Abnormal liver function tests associated with esketamine use have been reported, particularly with extended
use (>3 days) or drug abuse. A prolonged duration of action may occur in patients with cirrhosis or other
types of liver impairment. Dose reductions should be considered in these patients.

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In diagnostic and therapeutic procedures of the upper respiratory tract, hyperreflexia and laryngospasms are
possible, especially in children. Muscle relaxants and controlled ventilation may therefore be necessary in
procedures on the pharynx, larynx and bronchi.
In surgical procedures that may involve visceral pain, muscle relaxation and supplemental analgesia
(controlled ventilation and administration of nitrous oxide/oxygen) are indicated.
Long-Term Use
Cases of cystisis, including hemorrhagic cystitis, have been reported in patients using racemic ketamine on a
long-term basis (one month to several years). Similar effects may also occur following esketamine abuse (see
below). Hepatotoxicity has also been reported in patients with extended use (> 3 days).
Drug Abuse and Dependence
Racemic ketamine has been reported being used as a drug of abuse. Reports suggest that racemic ketamine
produces a variety of symptoms including, among others, flashbacks, hallucinations, dysphoria, anxiety,
insomnia, or disorientation. Cases of cystitis, including hemorrhagic cystitis, and cases of hepatotoxicity
have also been reported. Similar effects therefore cannot be ruled out following esketamine use.
Esketamine dependence and tolerance may develop in individuals with a history of drug abuse or
dependence. Therefore, esketamine should be prescribed and administered with caution.
The risk of psychic reaction occurring during recovery from anaesthesia can be greatly reduced by the
co-administration of a benzodiazepine.

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Overdose
The clinical symptoms of overdose are convulsion, cardiac arrhythmia and respiratory arrest.
Respiratory arrest must be treated by assisted or controlled ventilation until sufficient spontaneous
respiration is achieved.
Convulsions should be treated with intravenous administration of diazepam. If treatment with diazepam does
not result in sufficient response, administration of phenytoin or thiopental is recommended.
No specific antidote is presently known.
Incompatibilities
Esketamine is chemically incompatible with barbiturates, diazepam and doxapram because of precipitate
formation. They are not to be administered with the same syringe and needle.
The medicinal product must not be mixed with other medicinal products except those mentioned in ”Special
precautions for handling.”
Special precautions for handling
Esketamine can be mixed with glucose 50 mg/ml and sodium chloride 9 mg/ml.
Parenteral products should be inspected visually for particulate matter and discolouration prior to
administration, whenever solution and container permit.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.